使用双离心法制备小型水性悬浮剂:工艺参数对药物颗粒大小的影响
Nadina Zulbeari1, Nanna Einshøj Lund1, René Holm1
1Department of Physics, Chemistry, and Pharmacy, University of Southern Denmark, Campusvej 55 5230, Odense, Denmark.
概括
双离心是制药悬浮剂的有效削工具. 速度,珠子大小和加载显著影响颗粒大小,更高的强度产生更小的颗粒.
科学领域:
- 制药技术 制药技术 制药技术
- 材料科学 材料科学 材料科学
- 化学工程是化学工程的重要组成部分.
背景情况:
- 双离心法提供了多个药物悬浮样本的快速,同时削.
- 现有的文献缺乏对双离心机过程变量及其对颗粒大小减小的影响的系统理解.
研究的目的:
- 系统地评估双离心机工艺参数对亚微米制药悬浮颗粒大小的影响.
- 为了确定最佳的研磨条件,以进行独立于特定药物化合物的小规模选.
主要方法:
- 三种模型化合物 (cinnarizine,haloperidol,indomethacin) 使用双离心法进行了研磨.
- 调查的关键参数包括削速度,珠子大小,珠子负荷和转子温度.
- 在各种条件下监测了颗粒体大小的减少,使用聚酸盐20作为稳定剂.
主要成果:
- 研磨速度 (高达每分钟1500转),较小的珠子尺寸 (0.2毫米) 和较高的珠子负载 (42-83%) 显著减少了颗粒大小.
- 转子温度没有影响聚酸盐20稳定悬浮物的颗粒大小配置.
- 磨削极限很快就达到了 (大约. 30分钟) 在最佳条件下,达到亚微米大小 (0.35-0.70微米).
结论:
- 双离心法适用于制药悬浮液的小规模选.
- 研磨强度,珠子大小和负载对于实现所需的颗粒大小至关重要.
- 对于像哈洛佩里多尔这样的塑料化合物来说,更高的研磨强度至关重要;随着长时间的研磨,印梅他的颗粒大小可能会增加.
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